JAMP-DONEPEZIL TABLETS

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DONEPEZIL HYDROCHLORIDE

제공처:

JAMP PHARMA CORPORATION

ATC 코드:

N06DA02

INN (국제 이름):

DONEPEZIL

복용량:

5MG

약제 형태:

TABLET

구성:

DONEPEZIL HYDROCHLORIDE 5MG

관리 경로:

ORAL

패키지 단위:

28/30/250

처방전 유형:

Prescription

치료 영역:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

제품 요약:

Active ingredient group (AIG) number: 0131548001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2013-12-27

제품 특성 요약

JAMP-DONEPEZIL TABLETS
(donepezil hydrochloride) Product Monograph
Page 1 of 51
PRODUCT MONOGRAPH
PR
JAMP-DONEPEZIL TABLETS
(donepezil hydrochloride)
Tablets 5 and 10 mg
CHOLINESTERASE INHIBITOR
JAMP PHARMA CORPORATION
1380-203 NEWTON STREET
BOUCHERVILLE, QUEBEC
J4B 5H2
DATE OF REVISION:
MARCH 12, 2015
Submission Control No: 182041
JAMP-DONEPEZIL TABLETS
(donepezil hydrochloride) Product Monograph
Page 2 of 51
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................22
PHARMACEUTICAL INFORMATION
..........................................................................22
CLINICAL TRIALS
.........................................................................